ID

32577

Description

Study ID: 106837 Clinical Study ID: HZA106837 Study Title: A Long-Term, Randomized, Double-Blind, Parallel Group Study of Fluticasone Furoate/GW642444 Inhalation Powder Once-Daily and Fluticasone Furoate Inhalation Powder Once-Daily in Subjects with Asthma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01086384 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: fluticasone furoate/vilanterol Trade Name: Relvar Study Indication: Asthma

Keywords

Versions (2)
  1. 11/7/18 11/7/18 -
  2. 12/7/18 12/7/18 -
Copyright Holder

GSK group of companies

Uploaded on

November 7, 2018

DOI

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License

Creative Commons BY-NC 3.0
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A Parallel Group Study of Fluticasone Furoate/Vilanterol in Subjects with Asthma - 106837

English

Liver Biopsy Data

1 forms  
  1. StudyEvent: ODM
    1. Liver Biopsy Data
Date of liver biopsy
Description

Date of liver biopsy

Date
Description

Date

Data type

date

Biopsy size
Description

Biopsy size

Approximate size of liver biopsy
Description

Approximate size of liver biopsy

Data type

integer

Measurement units
  • mm
mm
Final diagnosis of biopsy
Description

Final diagnosis of biopsy

Final diagnosis
Description

Final diagnosis

Data type

text

If ABNORMAL, check YES for all that apply
Description

If ABNORMAL, check YES for all that apply

Data type

text

Acute hepatitis
Description

Acute hepatitis

Data type

boolean

Chronic hepatitis
Description

Chronic hepatitis

Data type

boolean

Cholestatic hepatitis
Description

Cholestatic hepatitis

Data type

boolean

Drug.induced cholestasis
Description

Drug.induced cholestasis

Data type

boolean

Acute viral hepatitis
Description

Acute viral hepatitis

Data type

boolean

Chronic viral hepatitis
Description

Chronic viral hepatitis

Data type

boolean

Drug-induced hepatitis
Description

Drug-induced hepatitis

Data type

boolean

Autoimmune hepatitis
Description

Autoimmune hepatitis

Data type

boolean

Bridging necrosis
Description

Bridging necrosis

Data type

boolean

Submassive hepatic necrosis
Description

Submassive hepatic necrosis

Data type

boolean

Massive hepatic necrosis
Description

Massive hepatic necrosis

Data type

boolean

Steatosis - microvesicular
Description

Steatosis - microvesicular

Data type

text

Steatosis - macrovesicular
Description

Steatosis - macrovesicular

Data type

boolean

Steatosis - mixed
Description

Steatosis - mixed

Data type

boolean

Non-alcoholic steatohepatitis
Description

Non-alcoholic steatohepatitis

Data type

boolean

Alcoholic hepatitis
Description

Alcoholic hepatitis

Data type

boolean

Hepatic granulomas
Description

Hepatic granulomas

Data type

boolean

Sarcoidosis
Description

Sarcoidosis

Data type

text

Fibrosis
Description

Fibrosis

Data type

boolean

Cirrhosis
Description

Cirrhosis

Data type

boolean

Primary biliary cirrhosis
Description

Primary biliary cirrhosis

Data type

boolean

Primary sclerosing cholangitis
Description

Primary sclerosing cholangitis

Data type

boolean

Autoimmune overlap syndrome
Description

Autoimmune overlap syndrome

Data type

boolean

Hemochromatosis
Description

Hemochromatosis

Data type

boolean

Alpha-1-antitrypsin deficiency
Description

Alpha-1-antitrypsin deficiency

Data type

boolean

Wilson's disease
Description

Wilson's disease

Data type

boolean

Veno-occlusive disease
Description

Veno-occlusive disease

Data type

boolean

Budd-Chiari syndrome
Description

Budd-Chiari syndrome

Data type

boolean

Neoplasia
Description

Neoplasia

Data type

boolean

Other, specify
Description

Other, specify

Data type

text

Liver architecture
Description

Liver architecture

check YES for all that apply
Description

check YES for all that apply

Data type

text

Normal
Description

Normal

Data type

boolean

Bridging fibrosis
Description

Bridging fibrosis

Data type

boolean

Diffuse fibrosis
Description

Diffuse fibrosis

Data type

boolean

Nodular regenerative hyperplasia
Description

Nodular regenerative hyperplasia

Data type

boolean

Congenital hepatic fibrosis
Description

Congenital hepatic fibrosis

Data type

boolean

Cirrhosis
Description

Cirrhosis

Data type

boolean

Centrilobular congestion
Description

Centrilobular congestion

Data type

boolean

Endophlebitis
Description

Endophlebitis

Data type

boolean

Veno-occlusive disease
Description

Veno-occlusive disease

Data type

boolean

Canalicular cholestasis
Description

Canalicular cholestasis

Data type

boolean

Apoptosis
Description

Apoptosis

Data type

boolean

Focal (or spotty or mild) hepatocellular necrosis
Description

Focal (or spotty or mild) hepatocellular necrosis

Data type

boolean

Interface hepatitis (periportal hepatitis or piecemeal necrosis)
Description

Interface hepatitis (periportal hepatitis or piecemeal necrosis)

Data type

boolean

Ischaemic necrosis
Description

Ischaemic necrosis

Data type

boolean

Centroloular (Zone 3) necrosis
Description

Centroloular (Zone 3) necrosis

Data type

boolean

Focal coagulative necrosis
Description

Focal coagulative necrosis

Data type

boolean

Centrolobular (Zone 3) coagulative necrosis
Description

Centrolobular (Zone 3) coagulative necrosis

Data type

boolean

Bridging hepatocellular necrosis
Description

Bridging hepatocellular necrosis

Data type

boolean

Massive or panlobular hepatocellular necrosis
Description

Massive or panlobular hepatocellular necrosis

Data type

boolean

Dysplasia
Description

Dysplasia

Data type

boolean

Neoplasia
Description

Neoplasia

Data type

boolean

Other, specify
Description

Other, specify

Data type

text

Description of Liver Cells or Hepatocytes
Description

Description of Liver Cells or Hepatocytes

Check all that apply
Description

Check all that apply

Data type

text

If OTHER, specify
Description

If OTHER, specify

Data type

text

Liver Cell or Hepatocyte Inclusions or Vacuoles
Description

Liver Cell or Hepatocyte Inclusions or Vacuoles

check YES for all that apply
Description

check YES for all that apply

Data type

text

No inclusions
Description

No inclusions

Data type

boolean

Macrovesicular steatosis
Description

Macrovesicular steatosis

Data type

boolean

Microvesicular steatosis
Description

Microvesicular steatosis

Data type

boolean

Bile accumulation
Description

Bile accumulation

Data type

boolean

Diastase - resistant, PAS-positive cytoplasmic inclusions
Description

Diastase - resistant, PAS-positive cytoplasmic inclusions

Data type

boolean

Alpha-1-antitrypsin inclusions
Description

Alpha-1-antitrypsin inclusions

Data type

boolean

Megamitochondria
Description

Megamitochondria

Data type

boolean

Mallory bodies
Description

Mallory bodies

Data type

boolean

"Ground Glass" inclusions
Description

"Ground Glass" inclusions

Data type

boolean

Lipofuscin pigment
Description

Lipofuscin pigment

Data type

boolean

Hemosiderin granules
Description

Hemosiderin granules

Data type

boolean

Orcein - positive cytoplasmin granules
Description

Orcein - positive cytoplasmin granules

Data type

boolean

Protoporphyrin crystals (birefringend under polarised light)
Description

Protoporphyrin crystals (birefringend under polarised light)

Data type

boolean

Uroporchyrin crystals (red fluorescence under ultraviolet light)
Description

Uroporchyrin crystals (red fluorescence under ultraviolet light)

Data type

boolean

Other, specify
Description

Other, specify

Data type

text

Hepatocyte or Liver Cell Nuclear Abnormalities
Description

Hepatocyte or Liver Cell Nuclear Abnormalities

check all that apply
Description

check all that apply

Data type

text

If OTHER, specify
Description

If OTHER, specify

Data type

boolean

Liver or Lobular Infiltrates
Description

Liver or Lobular Infiltrates

check all that apply
Description

check all that apply

Data type

text

If OTHER, specify
Description

If OTHER, specify

Data type

text

Portal tract Inflamation
Description

Portal tract Inflamation

check all that apply
Description

check all that apply

Data type

text

If OTHER, specify
Description

If OTHER, specify

Data type

text

Bile ducts
Description

Bile ducts

check all that apply
Description

check all that apply

Data type

text

If OTHER, specify
Description

If OTHER, specify

Data type

boolean

Portal veins
Description

Portal veins

check all that apply
Description

check all that apply

Data type

text

If OTHER, specify
Description

If OTHER, specify

Data type

text

Liver Infections
Description

Liver Infections

Check all that apply
Description

Check all that apply

Data type

text

If OTHER, specify
Description

If OTHER, specify

Data type

text

Parasites or Ova
Description

Parasites or Ova

check all that apply
Description

check all that apply

Data type

text

If OTHER, specify
Description

If OTHER, specify

Data type

text

Histologic Staining or Additional Studies Obtained
Description

Histologic Staining or Additional Studies Obtained

Check YES for all that apply
Description

Check YES for all that apply

Data type

text

Haematoxylin and eosin (or H & E)
Description

Haematoxylin and eosin (or H & E)

Data type

boolean

Masson
Description

Masson

Data type

boolean

Toluidine blue or Giemsa
Description

Toluidine blue or Giemsa

Data type

boolean

Prussian blue
Description

Prussian blue

Data type

boolean

Periodic Acidic Schiff (PAS), with or without diastase
Description

Periodic Acidic Schiff (PAS), with or without diastase

Data type

boolean

Oil red O
Description

Oil red O

Data type

boolean

Congo red
Description

Congo red

Data type

boolean

Hall's stain
Description

Hall's stain

Data type

boolean

Gridley's stain
Description

Gridley's stain

Data type

boolean

Rhodanine (copper)
Description

Rhodanine (copper)

Data type

boolean

Rubeanic acid (copper)
Description

Rubeanic acid (copper)

Data type

boolean

Orcein, aldehyde fuchsin or Victoria blue
Description

Orcein, aldehyde fuchsin or Victoria blue

Data type

boolean

Electron microscopy
Description

Electron microscopy

Data type

boolean

Hepatitis A immunistains positive
Description

Hepatitis A immunistains positive

Data type

boolean

Hepatitis B core antigen or hepatitis B surface antibody immunostains positive
Description

Hepatitis B core antigen or hepatitis B surface antibody immunostains positive

Data type

boolean

Hepatitis D immunostains
Description

Hepatitis D immunostains

Data type

boolean

Other immunostains
Description

Other immunostains

Data type

boolean

Other, specify
Description

Other, specify

Data type

text

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Similar models

Liver Biopsy Data

1 forms
  1. StudyEvent: ODM
    1. Liver Biopsy Data
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Date of liver biopsy
Date
Item
Date
date
Item Group
Biopsy size
Approximate size of liver biopsy
Item
Approximate size of liver biopsy
integer
Item Group
Final diagnosis of biopsy
Item
Final diagnosis
text
Final diagnosis
Code List
Final diagnosis
CL Item
Normal (1)
CL Item
Abnormal (2)
If ABNORMAL, check YES for all that apply
Item
If ABNORMAL, check YES for all that apply
text
Acute hepatitis
Item
Acute hepatitis
boolean
Chronic hepatitis
Item
Chronic hepatitis
boolean
Cholestatic hepatitis
Item
Cholestatic hepatitis
boolean
Drug.induced cholestasis
Item
Drug.induced cholestasis
boolean
Acute viral hepatitis
Item
Acute viral hepatitis
boolean
Chronic viral hepatitis
Item
Chronic viral hepatitis
boolean
Drug-induced hepatitis
Item
Drug-induced hepatitis
boolean
Autoimmune hepatitis
Item
Autoimmune hepatitis
boolean
Bridging necrosis
Item
Bridging necrosis
boolean
Submassive hepatic necrosis
Item
Submassive hepatic necrosis
boolean
Massive hepatic necrosis
Item
Massive hepatic necrosis
boolean
Steatosis - microvesicular
Item
Steatosis - microvesicular
text
Steatosis - macrovesicular
Item
Steatosis - macrovesicular
boolean
Steatosis - mixed
Item
Steatosis - mixed
boolean
Non-alcoholic steatohepatitis
Item
Non-alcoholic steatohepatitis
boolean
Alcoholic hepatitis
Item
Alcoholic hepatitis
boolean
Hepatic granulomas
Item
Hepatic granulomas
boolean
Sarcoidosis
Item
Sarcoidosis
text
Fibrosis
Item
Fibrosis
boolean
Cirrhosis
Item
Cirrhosis
boolean
Primary biliary cirrhosis
Item
Primary biliary cirrhosis
boolean
Primary sclerosing cholangitis
Item
Primary sclerosing cholangitis
boolean
Autoimmune overlap syndrome
Item
Autoimmune overlap syndrome
boolean
Hemochromatosis
Item
Hemochromatosis
boolean
Alpha-1-antitrypsin deficiency
Item
Alpha-1-antitrypsin deficiency
boolean
Wilson's disease
Item
Wilson's disease
boolean
Veno-occlusive disease
Item
Veno-occlusive disease
boolean
Budd-Chiari syndrome
Item
Budd-Chiari syndrome
boolean
Neoplasia
Item
Neoplasia
boolean
Other, specify
Item
Other, specify
text
Item Group
Liver architecture
check YES for all that apply
Item
check YES for all that apply
text
Normal
Item
Normal
boolean
Bridging fibrosis
Item
Bridging fibrosis
boolean
Diffuse fibrosis
Item
Diffuse fibrosis
boolean
Nodular regenerative hyperplasia
Item
Nodular regenerative hyperplasia
boolean
Congenital hepatic fibrosis
Item
Congenital hepatic fibrosis
boolean
Cirrhosis
Item
Cirrhosis
boolean
Centrilobular congestion
Item
Centrilobular congestion
boolean
Endophlebitis
Item
Endophlebitis
boolean
Veno-occlusive disease
Item
Veno-occlusive disease
boolean
Canalicular cholestasis
Item
Canalicular cholestasis
boolean
Apoptosis
Item
Apoptosis
boolean
Focal (or spotty or mild) hepatocellular necrosis
Item
Focal (or spotty or mild) hepatocellular necrosis
boolean
Interface hepatitis (periportal hepatitis or piecemeal necrosis)
Item
Interface hepatitis (periportal hepatitis or piecemeal necrosis)
boolean
Ischaemic necrosis
Item
Ischaemic necrosis
boolean
Centroloular (Zone 3) necrosis
Item
Centroloular (Zone 3) necrosis
boolean
Focal coagulative necrosis
Item
Focal coagulative necrosis
boolean
Centrolobular (Zone 3) coagulative necrosis
Item
Centrolobular (Zone 3) coagulative necrosis
boolean
Bridging hepatocellular necrosis
Item
Bridging hepatocellular necrosis
boolean
Massive or panlobular hepatocellular necrosis
Item
Massive or panlobular hepatocellular necrosis
boolean
Dysplasia
Item
Dysplasia
boolean
Neoplasia
Item
Neoplasia
boolean
Other, specify
Item
Other, specify
text
Item Group
Description of Liver Cells or Hepatocytes
Item
Check all that apply
text
Check all that apply
Code List
Check all that apply
CL Item
Normal (1)
CL Item
Ballooning (2)
CL Item
Acidophilic (3)
CL Item
Pseudoxanthomatous (4)
CL Item
Multinucleated giant hepatocytes (5)
CL Item
Other (6)
If OTHER, specify
Item
If OTHER, specify
text
Item Group
Liver Cell or Hepatocyte Inclusions or Vacuoles
check YES for all that apply
Item
check YES for all that apply
text
No inclusions
Item
No inclusions
boolean
Macrovesicular steatosis
Item
Macrovesicular steatosis
boolean
Microvesicular steatosis
Item
Microvesicular steatosis
boolean
Bile accumulation
Item
Bile accumulation
boolean
Diastase - resistant, PAS-positive cytoplasmic inclusions
Item
Diastase - resistant, PAS-positive cytoplasmic inclusions
boolean
Alpha-1-antitrypsin inclusions
Item
Alpha-1-antitrypsin inclusions
boolean
Megamitochondria
Item
Megamitochondria
boolean
Mallory bodies
Item
Mallory bodies
boolean
"Ground Glass" inclusions
Item
"Ground Glass" inclusions
boolean
Lipofuscin pigment
Item
Lipofuscin pigment
boolean
Hemosiderin granules
Item
Hemosiderin granules
boolean
Orcein - positive cytoplasmin granules
Item
Orcein - positive cytoplasmin granules
boolean
Protoporphyrin crystals (birefringend under polarised light)
Item
Protoporphyrin crystals (birefringend under polarised light)
boolean
Uroporchyrin crystals (red fluorescence under ultraviolet light)
Item
Uroporchyrin crystals (red fluorescence under ultraviolet light)
boolean
Other, specify
Item
Other, specify
text
Item Group
Hepatocyte or Liver Cell Nuclear Abnormalities
Item
check all that apply
text
check all that apply
Code List
check all that apply
CL Item
None (1)
CL Item
Hepatocellular mitosis (2)
CL Item
Binucleated or multinucleated hepatocytes (3)
CL Item
CMV inclusion bodies (4)
CL Item
HSV inclusions (5)
CL Item
Varicella inclusions (6)
CL Item
Other (7)
If OTHER, specify
Item
If OTHER, specify
boolean
Item Group
Liver or Lobular Infiltrates
Item
check all that apply
text
check all that apply
Code List
check all that apply
CL Item
None (1)
CL Item
Eosinophils (2)
CL Item
Lymphosites (3)
CL Item
Plasma cells (4)
CL Item
Neutrophils (5)
CL Item
Macrophages and proliferating Kupffer cells (6)
CL Item
Granulomas (7)
CL Item
Other (8)
If OTHER, specify
Item
If OTHER, specify
text
Item Group
Portal tract Inflamation
Item
check all that apply
text
check all that apply
Code List
check all that apply
CL Item
None (1)
CL Item
Eosinophils (2)
CL Item
Lymphoid aggregates and/or follicles (3)
CL Item
Plasma cells (4)
CL Item
Neutrophils (5)
CL Item
Histocytes and macrophages (6)
CL Item
Other (7)
If OTHER, specify
Item
If OTHER, specify
text
Item Group
Bile ducts
Item
check all that apply
text
check all that apply
Code List
check all that apply
CL Item
Normal (1)
CL Item
Proliferation of bile ducts (bile ductular reaction) (2)
CL Item
Dilation, degeneration or disruption of portal bile ducts (3)
CL Item
Paucity of bile ducts (4)
CL Item
Periductal fibrosis (5)
CL Item
Other (6)
If OTHER, specify
Item
If OTHER, specify
boolean
Item Group
Portal veins
Item
check all that apply
text
check all that apply
Code List
check all that apply
CL Item
Normal (1)
CL Item
Pyelophlebitis (2)
CL Item
Thrombosis, sclerosis or occlusion of portal vein (3)
CL Item
Neoplastic invasion of portal vein (4)
CL Item
Granulomatous compression of portal vein (5)
CL Item
Other (6)
If OTHER, specify
Item
If OTHER, specify
text
Item Group
Liver Infections
Item
Check all that apply
text
Check all that apply
Code List
Check all that apply
CL Item
Normal (1)
CL Item
Leishmaniasis donovani (2)
CL Item
Plasmodium falciparum (3)
CL Item
Toxooplasmosis (4)
CL Item
Cryptococcus neoformans (5)
CL Item
Histoplasma capsulatum (6)
CL Item
Mycobacterium tuberculosis (7)
CL Item
Other mycrobacterial species (8)
CL Item
Other (9)
If OTHER, specify
Item
If OTHER, specify
text
Item Group
Parasites or Ova
Item
check all that apply
text
check all that apply
Code List
check all that apply
CL Item
None (1)
CL Item
Schistosome and/or ova (2)
CL Item
Ascaris and/or ova (3)
CL Item
Toxocara and/or ova (4)
CL Item
Echinococcus cysts (5)
CL Item
Hepatic capillariasis worms and/or ova (6)
CL Item
Other (7)
If OTHER, specify
Item
If OTHER, specify
text
Item Group
Histologic Staining or Additional Studies Obtained
Check YES for all that apply
Item
Check YES for all that apply
text
Haematoxylin and eosin (or H & E)
Item
Haematoxylin and eosin (or H & E)
boolean
Masson
Item
Masson
boolean
Toluidine blue or Giemsa
Item
Toluidine blue or Giemsa
boolean
Prussian blue
Item
Prussian blue
boolean
Periodic Acidic Schiff (PAS), with or without diastase
Item
Periodic Acidic Schiff (PAS), with or without diastase
boolean
Oil red O
Item
Oil red O
boolean
Congo red
Item
Congo red
boolean
Hall's stain
Item
Hall's stain
boolean
Gridley's stain
Item
Gridley's stain
boolean
Rhodanine (copper)
Item
Rhodanine (copper)
boolean
Rubeanic acid (copper)
Item
Rubeanic acid (copper)
boolean
Orcein, aldehyde fuchsin or Victoria blue
Item
Orcein, aldehyde fuchsin or Victoria blue
boolean
Electron microscopy
Item
Electron microscopy
boolean
Hepatitis A immunistains positive
Item
Hepatitis A immunistains positive
boolean
Hepatitis B core antigen or hepatitis B surface antibody immunostains positive
Item
Hepatitis B core antigen or hepatitis B surface antibody immunostains positive
boolean
Hepatitis D immunostains
Item
Hepatitis D immunostains
boolean
Other immunostains
Item
Other immunostains
boolean
Other, specify
Item
Other, specify
text
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